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IMagyn050 YO39523/GOG-3015/ENGOT-ov39 Recruitment Update

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Presentation on theme: "IMagyn050 YO39523/GOG-3015/ENGOT-ov39 Recruitment Update"— Presentation transcript:

1 IMagyn050 YO39523/GOG-3015/ENGOT-ov39 Recruitment Update
17 Jun 2018

2 ENGOT Ov-39 Trial IMaGYN 050 Study Design
Study Design in Neoadjuvant Cohort Previously untreated ovarian, fallopian tube, or peritoneal cancer Stage III / IV, Unresectable advanced stage patients for neoadjuvant therapy ECOG PS 0-2 R 1:1 Carboplatin AUC 6 Bev 15 mg/kg X 16 cycles Placebo q3w X 22 cycles Paclitaxel 175 mg/m2 Bev 15 mg/kg Atezo 1200 mg q3w X 22 cycles No cross-over SURGERY Key Points: Reason for NACT must be disease-related (e.g., location/bulk of disease making patient unresectable to R0), based on Fagotti Interval surgery must be b/w C3 & D4 No bev C3 & C4 b/c of surgery

3 IMagyn050 Recruitment Summary (as of 17 Jun 2018)
Number Of Last Month (31 May 2018) Current Month (17 Jun 2018) Target for Month % Countries Open 22 100 % Sites Activated 278+39* 279+39* 284 98% Sites Screening 215+12* 217+14* - 78% Pts In-Screening 52 Enrollment Adjuvant 362 395 Neoadjuvant 328 330 Neoadjuvant Biomarker 24 Cumulative Total 690 725 601 120% Recr Rate (Pts/site/mo) 0.45 0.13 Screen Failures** 156 (19%) 172 (19%) * US satellite sites ** Overall SF% = SF Pts / (Rand Pts + SF Pts)

4 IMagyn050 Recruitment Summary (as of 17 Jun 2018)

5 IMagyn050 Countries Summary (as of 17 Jun 2018)
Countries (Community) Site Activation Planned Actual Recruitment Planned Actual USA (GOG) 132 550 290 Austria (AGO Austria) 4 10 8 Belgium (BGOG) 38 7 Czech Rep(CEEGOG) 17 12 Denmark (NSGO) 2 13 1 Finland (NSGO) 3 9 Norway (NSGO) 11 Sweden (NSGO) 16 France (GINECO) 39 Germany (AGO) 20 65 22 Greece (HECOG) 5 37 Israel (ISGO) Italy (MaNGO) 29 Italy (MITO) 42 34 Poland (PGOG) 6 15 Spain (GEICO) 35 Turkey (TRSGO) 26 Japan (Chugai) 120 67 China 150 Australia 18 Brazil 14 Russian Federation South Korea 31 Region / Community Total Recruitment Planned Actual % of Goal GOG (US) 550 290 52.7% ENGOT (EU) 420 204 48.6% Chugai(Japan) 120 67 55.8% China 150 34 22.7% ROW 60 130 216.7%


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